Continuous Chest Wall Vibration in COPD Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2019-09-30

Brief Summary

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Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Previous study show that chest wall vibration decrease dyspnea in COPD patients and precisely when applied during the inspiration phase, called "in-phase vibration" (IPV) which provide vibration directly on intercostal muscles. These findings have been obtained in laboratory context and the intercostals muscles vibration has been tested only in single phases of breathing, during inspiration with IPV and during exhalation with out-of-phase vibration (OPV). None study has evaluated the effect of a continuous chest wall vibration (CCWV), namely muscles vibration during the whole cycle of breathing, on dyspnea in patients with COPD in a clinical context. Continuous high frequency vibration has been proven to reduce myoelectrical manifestation of fatigue, probably modifying the centrally driven motor unit recruitment hierarchy, in healthy subjects.

Moreover, CCWV is a modality of provide vibration more suitable and cost-effective in a clinical context than single-phases vibration that requires specific instruments for the detection of breathing phases and the coupling with vibration device.

On these bases, the investigators hypothesized that CCWV at high frequency, applied during a cycle ergometer training program, could decrease dyspnea and enhance the exercise tolerance in COPD patients. Therefore, the aim of this study is to evaluate the effects of high frequency CCWV on dyspnea and exercise tolerance in patients with COPD patients compared to usual care and to sham intervention.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Cycle ergometer training program: 2 minutes warm-up at no load, 20 minutes at 60% of peak work (PW) calculated by stress-test or at 50% of PW calculated according to Luxton equation (PW = 103.217 + (30.50 X gender) + (-1.613 X age) + (0.002 X 6MWW \[m kg -1 \]). The progression of the workloads is calculated according to the BORG Dyspnea and Fatigue Scale (Borg D and F \< 5: 10W increase; Borg D and/or F between 5 e 6: maintain same workload; Borg D and / or \> 6: 10W decrease) Patient tailored airway clearance program guided by an experienced respiratory physical therapist, which could includes active cycle of breathing technique (ACBT), forced expiratory technique (FET), ELTGOL (slow expiration with glottis open in the lateral position) and PEP techniques (positive expiratory pressure).

Group Type ACTIVE_COMPARATOR